This story was originally published March 8.
Despite the increasingly competitive noninvasive prenatal testing market, Sequenom said that sales of its MaterniT21 Plus test have continued to grow, and were key in more than doubling the firm's revenues in the fourth quarter of 2012 over those of the previous year's quarter.
The company finished the quarter with $33.7 million in revenue, a 117 percent increase from its fourth quarter 2011 revenues of $15.5 million.
Sequenom accessioned more than 61,000 MaterniT21 Plus tests during the year, beating its most recent internal goal of 50,000. It ended the year with an annualized testing run rate of 120,000, or more than 2,300 tests per week, CEO Harry Hixson said during a conference call discussing the company's fourth-quarter results.
That growth, he said, has continued into 2013. "As a result of this, we have had to increase the capacity of [Sequenom Center for Molecular Medicine's] San Diego location and accelerated efforts to validate and initiate commercial operations at the SCMM North Carolina location," he said. Bringing the North Carolina facility online in the second half of the year will boost the firm's MaterniT21 Plus testing capacity to 300,000 from 200,000. Additionally, Sequenom plans to hire 10 more sales representatives, increasing its sales force to over 85 by the end of the first quarter.
As Hixson said at this year's JP Morgan Healthcare conference in January, the company is aiming to run more than 150,000 tests in 2013, and "we are confident that we will achieve this," he said on this week's call.
Hixson did not comment directly on competing tests and how the firm plans to stay competitive in an increasingly crowded market, particularly as other companies launch tests with significantly lower prices, saying only that Sequenom believes its test "sets the highest standard in the NIPT market by providing the highest accuracy with clear positive or negative test results, the broadest test menu, the shortest turnaround time, the lowest non-reportable result rate, and the highest level of customer responsiveness."
Nevertheless, at least one competitor, Ariosa, seems to be gaining ground on Sequenom. Ariosa launched its test in June 2012, and in January said that it had reached an annualized run rate of 100,000 tests, with 22,000 tests sold in the fourth quarter of 2012.
Sequenom's other main competitor, Verinata Health, has not disclosed the number of tests it has sold or its run rate, but the firm was acquired by Illumina in January for up to $450 million, which could give it a competitive edge (CSN 1/9/2013). Additionally, competitor Natera launched its test on a limited basis this month and plans to offer it broadly in April through Quest Diagnostics and Bio-Reference Laboratories (CSN 2/20/2013).
Sequenom did not disclose the number of tests it ran during the fourth quarter of 2012, and Hixson said the company will update its annualized run rate when it reports its quarterly results "as a measure of our progress in penetrating the high-risk NIPT market."
This shift away from incremental updates in test uptake is a change that left some analysts frustrated. "This move to a delayed metric rather than real-time in a space moving as quickly as this one is frustrating and may lead to questions about the impact of competition" on the test's sales, Brian Weinstein of William Blair wrote in a note.
On the reimbursement front, Sequenom has yet to ink contracts with national providers, although United Healthcare, Aetna, and WellPoint all recently said they support covering noninvasive prenatal tests, but stopped short of guaranteeing coverage.
Sequenom originally set a goal of securing contracts with two major national insurers by the end of 2012 — a goal that it failed to meet. During the call, Hixson said that the company is moving forward and still has goals to get contracts. But even without contracts, "third party payers are increasingly providing coverage," and as of the end of 2012, the company had 56 million lives under contract.
Despite these assurances, some analysts were concerned by the absence of contracts.
"It remains unclear when [Sequenom] will sign their first contract with a national payer," Credit Suisse analyst Vamil Divan wrote in a note. "We remain concerned that the lower list prices offered by Sequenom's competitors will significantly limit how much Sequenom will be able to obtain per test."
Sequenom bills insurance companies $2,900 for their test, charging insured patients no more than a $235 copay and uninsured patients $1,700. Meantime, Verinata's Verifi test costs around $1,200 and Ariosa's test is priced at $795. Natera has not yet disclosed the price of its test.
Added William Blair's Weinstein: "Reimbursement is becoming as important as uptake, if not even more important, and the lack of visual progress here is becoming a little worrisome."
Oppenheimer's David Ferreiro, however, was more optimistic and said that Sequenom remains "competitively positioned" despite Ariosa's "undercutting on price." Additionally, he expects "near-term" contracts with Aetna and WellPoint "based on positive assessments."
While Sequenom's 2012 fourth-quarter revenues more than doubled over the previous year's quarter driven primarily by revenues from its MaterniT21 Plus test, the company's ongoing litigation with Verinata, Ariosa, and Natera was a major cost during the quarter.
Selling, general, and administration expenses rose to $13.2 million from $6.8 million year over year, "due primarily to increased litigation expenses and increased infrastructure to support operations," chief financial officer Paul Maier said during the call. For the full year, operational expenses increased to $140.1 million from $103.8 million in 2011, due to "higher selling and marketing expenses to penetrate the market for NIPT, higher legal costs associated with patent litigation, and infrastructure to support our growth," he added.
"Clearly, legal expense was a driver of SG&A last year, and it represented a good portion of the growth and the volatility that we saw," Maier said. "We would expect there to continue to be volatility in that particular category, but it's very difficult to give any expectation of a pattern because … we don't have control over the timing" of the legal process.
Aside from litigation expenses, the company's research and development costs also rose in the fourth quarter to $14.3 million compared to $13.1 million in the fourth quarter of 2011, due primarily to expanding its capacity and progress toward validating and bringing online its North Carolina facility.
Net loss was $32.8 million, compared to $22.2 million in the year ago quarter. For the year, net loss was $117.1 million, compared to $74.2 in 2011.
Revenues from the company's diagnostic business were particularly strong, growing to $21.1 million in the last quarter of 2012, from $2.8 million in the previous year's quarter; and for the full year, diagnostic revenues represented 52 percent of the company's total revenues, surpassing its genetic analysis business for the first time. Revenues from the GA business were remained flat at $12.6 million.
For full-year 2012 Sequenom reported revenues of $89.7 million, up 60 percent from $55.9 million in 2011.
Sequenom finished the year with cash, cash equivalents, and marketable securities of $175.9 million.